- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00066677
Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well they work compared to bevacizumab alone in treating patients with metastatic pancreatic cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the progression-free survival of patients with previously treated metastatic pancreatic adenocarcinoma treated with bevacizumab with or without docetaxel.
- Determine the objective response rate and overall survival of patients treated with these regimens.
- Determine the incidence of thromboembolic events in patients treated with these regimens.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV over 1 hour on days 1, 8, and 15.
- Arm II: Patients receive bevacizumab as in arm I. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas
- Metastatic disease
Unidimensionally measurable disease outside of the pancreas
- At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- Must have received 1, and only 1, prior gemcitabine-containing regimen for metastatic disease unless disease has recurred within 6 months after treatment with neoadjuvant or adjuvant gemcitabine-containing therapy
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.0 g/dL (transfusion allowed)
- No bleeding diathesis or coagulopathy
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- AST and ALT no greater than 1.5 times ULN
- INR no greater than ULN
- PTT no greater than ULN
Renal
- Creatinine no greater than 2.0 mg/dL
- No clinically significant renal impairment
- Urine protein:creatinine ratio ≥ 1.0
Cardiovascular
- No prior myocardial infarction
- No prior stroke
- No clinically significant cardiovascular disease
- No uncontrolled hypertension (i.e., blood pressure greater than 160/110 mm Hg on medication)
- No unstable angina
- No New York Heart Association class II-IV congestive heart failure
- No serious cardiac dysrhythmia requiring medication
- No peripheral vascular disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history or evidence of CNS disease (e.g, primary brain tumor or seizures not controlled with standard medical therapy)
- No other medical condition that would preclude study participation
- No psychiatric condition that would preclude study participation
- No other prior or concurrent malignancy that would preclude study participation
- No significant traumatic injury within the past 28 days
- No serious, nonhealing wound, ulcer, or bone fracture
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent prophylactic granulocyte or platelet growth factors
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- More than 7 days since prior fine needle aspirations or core biopsies
- More than 28 days since prior surgery (except closed biopsy or access port placement)
- More than 28 days since prior open biopsy
- No concurrent surgery
Other
- More than 4 weeks since prior experimental drug study participation
- More than 4 weeks since prior investigational drugs
- No other concurrent experimental drug study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rhuMAB-VEGF
bevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference.
|
|
Experimental: rhuMAB-VEGF and Docetaxel
rhuMAB-VEGF,bevacizumab: 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks docetaxel, Taxotere: 35 mg/m2 given intravenously over 1 hour on days 1, 8, and 15 of each 28 day cycle.
Treatment continued until evidence of disease progression, unacceptable toxicity, or patient preference.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free Survival
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Response Rate
Time Frame: 56 days
|
56 days
|
Overall Survival
Time Frame: From date of registration until the date of death, assessed up to 5 years
|
From date of registration until the date of death, assessed up to 5 years
|
Number of Participants With Thromboembolic Events
Time Frame: 93 days
|
93 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Steven J. Cohen, MD, Fox Chase Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- CDR0000316454
- P30CA006927 (U.S. NIH Grant/Contract)
- FCCC-03003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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